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Recruiting NCT06289478

Efficacy and Safety of Topical Tranexamic Acid (TXA) Administration Cementless Bipolar Hemiarthroplasty for Femoral Neck Fracture - a Randomized Controlled Trial

No phase Interventional Femoral Neck Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retrograde Intraarticular Injection via Drain Tube, Topical Soaking of Tranexamic Acid, Placebo Comparator: Standard procedure (placebo).
Who it may be relevant to
Registry conditions: Femoral Neck Fracture. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Bipolar Hemiarthroplasty

Overview

The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are: * The efficacy in reducing blood transfusion for topical tranexamic acid administration * The safety of tranexemic acid, topically used As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration. Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.

Detailed description

Perioperative blood loss and transfusion are common in elderly patients undergoing bipolar hemiarthroplasty for femoral neck fractures, and are associated with anemia-related morbidity and transfusion-related risk. Although tranexamic acid (TXA) reduces blood loss and transfusion in elective arthroplasty, topical administration has been proposed to preserve local hemostatic efficacy while limiting systemic exposure in this comorbid population, but the optimal topical route in hip fracture surgery remains uncertain.

This study compared the efficacy and safety of topical soaking (TS) and intra-articular (IA) TXA with placebo in patients undergoing bipolar hemiarthroplasty.

Interventions

  • Drug Retrograde Intraarticular Injection via Drain Tube
    Tranexamic acid will be injected via drain tube after wound closure
  • Drug Topical Soaking of Tranexamic Acid
    Tranexamic acid will be topically administered by soaking method
  • Drug Placebo Comparator: Standard procedure (placebo)
    Standard wound management

Primary outcome measures

  • Rate of blood transfusion [Time frame: 2 years, or until complete enrollment]
Secondary outcome measures (4)
  • Volume of blood transfusion [Time frame: 2 years, or until complete enrollment]
  • Calculated blood loss [Time frame: 2 years, or until complete enrollment]
  • Any adverse events [Time frame: 2 years, or until complete enrollment]
  • In-hospital mortality [Time frame: During admission period]

Eligibility criteria

Inclusion criteria

  • Elderly patients (age \> 60 years)
  • Femoral neck fractures from low energy mechanism
  • Household ambulator
  • Undergoing cementless bipolar hemiarthroplasty at KCMH
  • Informed consent

Exclusion criteria

  • Allergy to TXA
  • History of VTE
  • History of hip surgery, pathological fracture, hip infection
  • Congenital or acquired coagulopathy
  • Hb \< 10 g/dL or Platelet \< 140,000

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Thailand · 2 centers
  • Faculty of Medicine, King Chulalongkorn Memorial Hospital — Bangkok
  • Faculty of Medicine — Bangkok

Identifiers

NCT: NCT06289478 · 0151/67

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗